System for securing sutures, grafts and soft tissue to bone and periosteum

ABSTRACT

Self-anchoring slings and deployment mechanisms for use therewith in selectively positioning a sling into position within the body. According to a preferred embodiment, the sling comprises an elongate sling portion having opposed ends. Formed upon each respective opposed end is an anchor member operative to be advanced through soft tissue at a selected target site in a first direction but resist movement in an opposed direction. Such anchor members are operative to extend in opposed directions to thus enable a sling to be securely affixed into position and resist sag or otherwise lose its ability to support a given structure. The deployment system is operative to selectively anchor the respective anchor members into position within a tissue mass. Although suitable for a wide variety of applications, it is believed that the system and sling of the present invention are particularly well suited for the deployment of suburethral slings via a trans-obturator route.

CROSS-REFERENCE TO RELATED APPLICATIONS

The following patent application is a continuation-in-part of U.S.patent application Ser. No. 09/733,455 entitled SYSTEM AND METHOD FORSECURING SUTURES TO BONE AND TISSUE, filed Dec. 8, 2000, which is acontinuation-in-part of U.S. patent application Ser. No. 09/197,938filed on Nov. 23, 1998 entitled SYSTEMS FOR SECURING SUTURES, GRAFTS ANDSOFT TISSUE TO BONE AND PERIOSTEUM, now issued as U.S. Pat. No.6,200,330, and further relies upon Disclosure Document No. 463,908entitled Transvaginal Rectus-Fascia Anchor, filed Oct. 21, 1999;Disclosure Document No. 479243 entitled Adjustable Soft TissueAttachment Device and System, filed Sep. 5, 2000; Disclosure Documententitled Transvaginal Rectus-Fascia Attachment, filed Mar. 1, 2000,disclosure document number not assigned; Disclosure Document entitledTransvaginal Attachment Delivery Tool, filed on or about Mar. 1, 2000,disclosure document number not assigned; Disclosure Document No. 463,825entitled Transvaginal Anchor Delivery Tool, filed on Oct. 21, 1999;Disclosure Document No. 458,659 entitled Transvaginal Adjustable System,filed Jul. 6, 1999; and Disclosure Document No. 480,805 entitledAdjustable Suture Soft Tissue Attachment System, filed Oct. 6, 2000, theteachings of all of which are incorporated herein by reference.

STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT

Not Applicable

BACKGROUND OF THE INVENTION

The use of surgical suture anchors for use in attaching soft tissue tobone is well known in the art. In this regard, such anchoring mechanismshave found widespread applicability for a number of surgical procedures,and in particular orthopedic, gynecologic and urologic procedures.Exemplary of such devices include bone screws or anchors that areimplantable within bone which further have formed thereon an eyelet orother type of assembly to which may be affixed suture lines or a segmentof soft tissue. Exemplary of such devices include those devicesdisclosed in U.S. Pat. Nos. 5,370,662, and 5,443,482 to Stone, et al.and U.S. Pat. No. 4,738,255 to Gobel, et al.

Generally, prior art anchor systems take one of two forms. The firstconfiguration typically comprises a self-tapping bone screw, typicallymade of titanium, having an eyelet formed thereon to which the suturesor other material may be attached. In the alternative prior artconfiguration, the device comprises an anchor member, which may take theform of an arrowhead or similar conical configuration, which furtherincludes a shaft or attachment member extending therefrom, the latterbeing formed to have one or more apertures to which the sutures or othermaterial may be attached.

With respect to the surgical installation of such devices, bone-screwmechanisms must necessarily be screwed in position, typically by abattery-powered screw driver, at a target site upon a particular bone.Anchor devices of the other aforementioned variety typically must be“shot” into position at a particular site within a bone, typically via aspring-loaded delivery mechanism. Exemplary of such bone-anchorinsertion devices include the In-Fast and In-Tac bone screw and boneanchor fixation devices previously produced by Influence, Inc. of SanFrancisco, Calif., now a division of American Medical Systems, Inc.

Although such prior art anchor devices generally provide sufficientsupport to the various sutures and grafts affixed thereto, such fixationdevices suffer from numerous drawbacks. In this regard, it is difficultfor the surgeon to accurately deploy the insertion device such that theanchor is correctly inserted at the target site. Moreover, substantialdifficulty arises in removing and adjusting such devices. This lattertask is especially problematic with respect to bone-screw devicesinsofar as the surgeon attempting to remove the same must take greatcare to insure that the removal device, also typically comprising abattery-powered screw driver, properly unscrews the anchor member fromits seated position. Other prior art anchor devices are even furtherproblematic insofar as the same are often irretrievable once deployed,especially in situations where the same are deployed too deeply into thebone mass.

Additional problems exist with prior art bone fixation systems insofaras the same have a tendency to become dislodged over time from theirseated position. In this regard, due to the repetitive application ofstress or strain upon the bone anchor via the suture or soft tissueattached thereto, such anchors can eventually become loose and slip outof engagement from their fixed position. This tendency is especiallylikely to the extent repetitive and persistent application of strain andstress is applied in one specific direction or orientation. Moreover,even to the extent such bone anchoring systems remain securely inposition, recent research tends to indicate that such bone fixationdevices have a tendency to actually cut the sutures sought to be heldthereby.

Separate and apart from the drawbacks associated with the use of priorart bone anchoring systems is the fact that often times anchor systemsprovide far more structural support than is necessary for a givensurgical application. In this respect, numerous surgical proceduresrequiring the fixation of sutures and/or soft tissue require only aminimal degree of tension. Exemplary of, and perhaps most well-known ofsuch procedures include transvaginal sling surgery to treatincontinence, which essentially involves the formation of a graftpositioned beneath the urethra with the opposed ends thereof beingsecured to either one of the abdominal fascia, Cooper's ligament orpubic bone. While such slings typically require little to no tensiononce fixed into position, due to the lack of alternative means foraffixing the opposed ends of such sling into position relative to thepubic bone, such prior art bone anchor devices must necessarily bedeployed. As a result, time spent in surgery is increased and thepatient undergoing such procedures in subjected to a far more traumaticexperience and has a possibly greater susceptibility of becominginfected by virtue of the deployment of such anchor devices than wouldotherwise occur to the extent alternative, less traumatic affixationdevices could be deployed. Along these lines, a substantial risk existssimply by utilizing a retropubic route to gain access to the surgicalsite where such sling is affixed into position. In this regard,accessing such surgical site via a retropubic route can increase therisk of bleeding and/or intestinal injury due to the proximity of bloodvessels existing within and above the pubocervical fascia and theintestines.

Accordingly, there is a need in the art for systems, devices and methodsfor affixing sutures, grafts, soft tissues, synthetic materials, and thelike to bone and soft tissue that are easier to deploy, manipulate andcan remain more firmly seated into position than prior art devices.There is additionally a need for such devices that can be utilized in awide variety of surgical applications and may be further customized foruse for particular applications such that an optimal degree of supportor leverage can be provided thereby. There is further a need in the artfor affixation systems, devices and methods that can provide for meansfor affixing sutures, grafts, soft tissues, synthetic materials, and thelike into position that are less traumatic, easier to deploy and adjust,and may be readily removed and repositioned at a particular site thanprior art systems and devices.

BRIEF SUMMARY OF THE INVENTION

The present invention specifically addresses and alleviates theabove-identified deficiencies in the art. In this regard, the presentinvention is directed to novel devices, systems and methods for theattachment of sutures, grafts and other types of tissues and materialsto bone, periosteum, ligaments, fascia and other soft tissue as may bewarranted in a given surgical procedure. The devices of type presentinvention are particularly well suited for the secure placement of oneor both of the opposed ends of a suburethral sling for use insuburethral sling surgery, but are by no means limited to suchparticular application.

In a first preferred embodiment, the invention comprises an implantimplantable within bone, ligaments, fascia and other soft tissue at adesired location. The implant comprises a piton portion designed topierce into and engage with the bone, or tissue, and a support structurecoupled therewith, the latter of which may take the form of a post, hookor eyelet to which the suture, graft, or tissue may be attached. Theimplants of the present invention may further include a handle memberformed thereon to facilitate the insertion and removal of the implantfrom its fixed or seated position within the bone/tissue.

The piton portion of the implant is specifically designed to become morefirmly embedded within the bone or other tissue when pressure is appliedto the support structure in a first direction, but may be dislodged orremoved when the implant is pulled in an opposed or second direction.The piton member may be further selectively sized and adapted for use ina particular application, and may be particularly designed to penetrateup to certain depths and/or be capable of supporting a specific quantityof mass or weight. In this regard, the implants may be designed to havetwo or more piton members, that each respectively provide means forsecurely attaching such implant to a desired side. Such implants may befurther configured such that multiple implants may be deployed upon alength of a suture, such that the suture may be selectively pulled andanchored into position along a desired pathway. In this respect, thepiton members may be formed such that the same are operative tofacilitate movement through tissue in one direction, yet perform ananchoring function in an opposite direction.

Such embodiment further advantageously allows for post-operativeadjustment whereby the suture with piton members attached thereto can beselectively pulled along the desired pathway to the extent necessary toadjust the suture position and/or introduce a greater degree of tensionthereto. Along these lines, such embodiment has the additional advantageof being completely removable from the patient's body by virtue of itsability to selectively move through and out of tissue.

In a second preferred embodiment, the invention comprises a discanchoring system that is operative to serve as a platform to whichsutures, graphs and the like may be secured or, alternatively, serve asa support for forming a suture “bridge”. According to one preferredversion, the affixation device comprises a disc or anchor plate which ispositionable upon a layer to tissue, such as a layer of muscle, fascia,or ligament, and in particular, the rectus fascia layer. The anchoringplate is preferably formed to be generally circular in nature andcomprised of an inner plate member encased within an annular outer platemember. The inner and outer plate members are further preferably formedsuch that at least one, and preferably two, diametrically opposedapertures are formed respectively therein for receiving suture linesinsertable therethrough. The inner plate and outer annular member areformed relative one another such that the inner plate is rotationalrelative the outer annular ring and operative to transition between afirst open configuration, wherein said apertures formed upon therespective plates are open to receive suture lines therethrough and asecond closed configuration, wherein rotation of the inner platerelative to the annular ring causes the apertures to close and lock,(i.e., crimp) any suture line extending therethrough to become rigidlysecured in position. To the extent desired, those portions of thesutures extending through the anchor plate may be affixed to one anotherto thus form a bridge or adjoining suture link.

In an alternative configuration, the disc anchoring system comprises adisc or anchor plate which is likewise positionable upon a layer oftissue (e.g., muscle, fascia, or ligament) that includes at least one,and preferably two to four, channels for receiving suture linesinsertable therethrough. The channel or channels are configured suchthat the same are crimpable such that when the suture line or lines areideally positioned therein or impart the necessary degree of support toan object (i.e., sling, graft, etc.), the crimping of such channel orchannels affixes such length of suture or sutures into position. Toachieve that end, it is contemplated that any of a variety ofconventional crimping devices may be deployed to impart the necessarycrimp in the channel or channels. As per the aforementioned embodiment,to the extent multiple suture lines extend through such plate, the samemay be tied, linked, crimped or otherwise joined to one another to forma suture bridge.

The disc anchoring system may further take the form of a system wherebya suture, having a plurality of protuberances formed therealong, isengageable with an anchor plate, the latter having an aperture formedtherein for receiving the suture line. As respective ones of theprotuberances extend through and rest against the anchor plate, thesuture line may thus be maintained in a fixed position relative adesired target site. Such embodiment advantageously provides forpost-operative adjustment should it become necessary to reposition thesuture or increase the tension within the suture line secured by thedisc anchoring system.

In all embodiments, the disc anchoring systems are particularly wellsuited for the use in pubovaginal sling surgery where it is necessary tosecure a sling such that the sling extends a desired distance from theurethra or exerts a desired degree of supportive pressure thereto, whichthus necessitates that such sling be selectively secured into positionvia the suture extending through the anchor plate. It will berecognized, however, that such disc anchoring systems may be utilizedfor a wide variety of medical applications and further, may be formed tobe permanently affixed into position or formed from a bio-absorbablematerial to the extent such anchoring systems need only remain residentfor a limited duration. Still further, it is contemplated that each ofthe aforementioned disc anchoring system may incorporate a load-bearingobject, such as a washer, mesh or other like structure, as part of or inconjunction with the disc anchoring system to facilitate thedistribution of stress and strain imparted thereto. As with the discsystem, such load distributing apparatus may be formed to be permanentlysecured into position or formed from an absorbable material.

In a third preferred embodiment, the invention comprises an affixationdevice designed to secure sutures, grafts, tissues, synthetic materials,and the like to periosteum (i.e., the thick fibrous membrane coveringthe surface of bones) and other soft tissue. According to a preferredembodiment, the affixation device includes a backing or base memberhaving at least one, and preferably a multiplicity of hook members thatare sized and adapted to hook into and ensnare with the periosteum ortissue. The hook members may be specifically designed to becomepartially embedded within the periosteum tissue, to thus providerelatively loose connection that is easier to remove, or adjust, and maybe designed to penetrate deeper within the periosteum tissue to thusprovide a more secure method of attachment. An attachment member formedupon the base member is further provided to which may be attached asuture or a portion of a graft.

In an alternative preferred embodiment, the invention comprises animplantable tack consisting of a hub member having at least one, andpreferably two or more hook members formed thereon, the latter beingdesigned to extend through the graft or tissue and become ensnared withand embedded in the periosteum such that the graft or tissue becomesinterposed between and affixed into position relative the tack andperiosteum. The affixation devices according to such embodiments arespecifically designed for selective attachment and detachment, and arefurther designed to provide more atraumatic means for the attachment ofthe suture or graft to a target location via the periosteum and softtissue. Such a fixation device, however, may be adapted such that thesame are designed to pierce into and become embedded with the bone, asper the other aforementioned embodiments.

In yet another embodiment of the present invention, there is provided anovel surgical staple that is also designed to secure a graft or othertypes of tissues and materials to the bone, periosteum, or other softtissue at a specific site or location. The staples of the presentinvention are preferably formed from plastically deformable materialshaving opposed ends that are designed to penetrate through thegraft/tissue and hook into the bone, periosteum or soft tissue at aselected site of fixation. Once secured in position, the staples areoperative to assume an expanded configuration such that the hooks formedthereby become more firmly embedded within the bone/tissue at the targetsite of fixation to thus further secure attachment of the graft thereto.Preferably, such staples may be fabricated from a shape-memory material,such as nitinol, which thus enables the staple to assume the compressedconfiguration when at room temperature, but transition to the operative,expanded configuration when warmed to body temperature, as will occurwhen the device is deployed. Such materials further enable the staplesof the present invention to be removed, as may be necessary, during agiven procedure or later procedures. Conversely, such staples may beformed from material that enable the same to compress or contract oncesecured into position to thus provide for a more secure means ofattachment.

The present invention further comprises novel surgical approaches forthe secure placement of a transvaginal sling during transvaginal slingsurgery. More particularly, such surgical procedure involves securingsuch sling into position, namely, beneath the urethra, with the opposedends thereof being secured to the posterior portion of the pubic bone,whether it be either the pubic bone itself or the periosteum surroundingthe same, in the retropubic space. The opposed ends of the sling may beattached to either the periosteum over the pubic bone or to the pubicbone itself using the novel affixation devices of the present invention.Advantageously, such surgical procedure eliminated the needs to form anabdominal incision, which typically must be made utilizing conventionalsurgical procedures. The novel affixation method of the presentinvention during such surgery further provides for the ingrowth of theopposed ends of the graft to a target site near or on the pubic bone orthe periosteum thereabout that eliminates any intervening pelvic fasciathat would otherwise become interposed between the anchor and opposedends of the sling sought to be secured into position.

As an alternative to the aforementioned approaches, the presentinvention further comprises novel systems and surgical techniques thatcan deploy anchoring systems for the placement of radio opaque markers,such as the TINED lead system of radio opaque markers produced byMedtronic, Inc., and pelvic floor reconstruction for support of pelvicorgans, such as through the use of slings affixed thereto, that arefixed into position via trans-obturator placement, as opposed toconventional retropubic surgical placement. Such surgical techniques,devices and systems utilized therewith are positioned utilizing a singlepercutaneous incision made in the vaginal epithelium which enables asling to be anchored into position in a target tissue, such as rectusand/or pubocervical fascia, via sling placement toward or through theobturator canal. To achieve that end, there is preferably provided adeployment system operative to selectively deploy and securely placeinto position a self-anchoring sling comprised of an elongate slinghaving opposed ends. Formed on each opposed end of such sling arededicated anchor mechanisms that are each operative to penetrate intoand become embedded within a target site of soft tissue, such as thepubocervical fascia.

Each respective anchor mechanism is operatively configured such thateach anchor mechanism is advanceable in a first direction through thesoft tissue at the target site but incapable of movement in an opposeddirection, (i.e., such anchor mechanisms are configured such that theopposed ends of the sling are capable of being advanced in opposeddirections but resisting or preventing contraction or other similar typeof motion drawing the ends towards one another). To facilitate suchmovement, it is contemplated that the anchor mechanisms may take theform of screws, arrowheads, prongs, and in particular generally Y-shapedor chevron shaped prongs, or any other structure that is capable ofbeing advanced in one direction yet resists or is biased againstmovement in an opposed direction. In further refinements such anchormechanisms may further be selectively configured to penetrate to adesired depth within a tissue mass, as well as may be selectivelyconfigured to assume a first compressed or deployment configuration suchthat the same will be operative to be positioned within a specifictarget site, and a second operative configuration whereby the anchormechanism expands or otherwise assumes a locking configuration thatenables the anchor to become affixed into position. In this regard, itis contemplated that the anchor mechanism may be formed to have anoutwardly expanding spring bias such that once released from a confinedposition automatically expands or anchors in an automatic fashion.

With respect to the deployment of such slings, it is contemplated thatthe same will be deployed through a manually operable deploymentmechanism. Preferably, such deployment mechanism will include a handlehaving a deployment member extending distally therefrom. With respect tothe latter, the deployment member will preferably be configured forinsertion through and under the vaginal wall to thus enable the slingswith anchor mechanisms formed thereon to be deployed via atrans-obturator or other route. To facilitate that end, it iscontemplated that the deployment member may be provided with a sharpeneddistal end capable of forming an incision within the vagina andthereafter be extensable under the vaginal wall to thus deploy theslings of the aforementioned variety within or near the obturator canal.In use, the sling having the anchoring mechanisms formed upon theopposed ends thereof will be coupled to or mounted upon the deploymentmember such that a respective one of the anchor mechanisms can bepositioned by the deployment member at a specified site within thetarget tissue (e. g., the pubocervical fascia or within the obturatorcanal). In this regard, it is contemplated that the deployment membermay be configured such that the anchor mechanisms will be deployed in asequential manner such that a first anchor is deployed in one targetsite and the other opposed anchor member deployed at a second site suchthat the sling disposed intermediate the anchor members can beselectively positioned to provide an optimal degree of support to theurethra. In order to manipulate such device, it is contemplated that thedeployment system will include an actuation member that enables thesurgeon to manually direct the advancement of the anchor mechanismcoupled with or mounted upon the deployment member of the mechanism tothus enable the self-anchoring sling to be controllably fixed intoposition. To facilitate such placement, it is contemplated that thedeployment member may be selectively curved or shaped to gain accessmore readily within a particular anatomical site, such as the obturatorcanal.

It is therefore an object of the present invention to provide surgicalimplantation devices to facilitate the attachment of sutures, grafts,tissues and the like to bone, periosteum and soft tissue that are easierto implant and remove than prior art devices, and are further capable ofproviding greater support or leverage to the structures coupledtherewith than prior art devices.

Another object of the present invention is to provide surgicalimplantation devices for the attachment of sutures, grafts, tissues andthe like to bone, periosteum and soft tissue that can be utilized in awide variety of surgical procedures, and in particular suburethral slingor other pelvic support surgery, and that may be further designed toprovide an optimal degree of support for a given quantity of mass orweight as may be necessary for a given surgical procedure.

Another object of the present invention is to provide devices for theaffixation of sutures, grafts, tissues and the like to periosteum andsoft tissue at a specific site or location that does not require anyanchoring mechanism to be inserted into the bone.

Another object of the present invention is to provide devices for theattachment of sutures, grafts, tissues and the like to bone, periosteumand soft tissue at a specific location that are less traumatic thanother prior art affixation devices.

Another object of the present invention is to provide devices for theattachment of sutures, grafts, tissues and the like to bone periosteumand soft tissue at a specific location that are easily attachable to anddetachable from a point of fixation than prior art devices andreattachable as may be necessary for a given procedure or futureprocedures.

Still further objects of the invention include methods and devices forsecuring sutures, grafts, tissues and the like to bone, periosteum andsoft tissue that are of simple construction, may be easily and readilyutilized for a variety of surgical procedures, may be readily adaptedfor use in a wide variety of surgical procedures, and provide an equal,if not greater degree of support or leverage than prior art devices.

Another object of the present invention is to provide a self-anchoringsling that enables the sling to be securely affixed into position with asite of soft tissue such that the same resists sag or otherwise lessensits ability to provide support that can further preferably be deployedvia a trans-obturator route, and preferably via a system and method thatenables the same to be deployed via a single access route, such as asingle vaginal incision, to thus eliminate risks associated with slingdelivery via a retro-pubic route.

It is additionally an object of the present invention to provide a novelsurgical procedure for the formation and affixation of a suburethralsling whereby the opposed ends of the sling are secured near or at theposterior side of the pubic bone in the retropubic space with theopposed ends of the sling being secured to either the periosteum,Cooper's ligament, fascia or the pubic bone itself.

BRIEF DESCRIPTION OF THE DRAWINGS

These, as well as other features of the present invention will becomemore apparent upon reference to the drawings wherein:

FIG. 1 is a frontal, cross-sectional view of the rectus fascia, pubicbone, urethra and vagina further depicting a sling member positionedabout the urethra or in which the respective ones of opposed ends of thesling are secured to the pubic bone.

FIG. 2 is a side cross-sectional view of the anatomical structuresdepicted in FIG. 1 and further depicting the fastening arrangement bywhich the sling is anchored to the posterior portion of the pubic bone.

FIG. 3 is a prior art surgical instrument utilized to secure the anchormember depicted in FIG. 2 to the posterior of the pubic bone.

FIG. 4 is a cross-sectional view of the pubic bone having a prior artanchor device secured thereto.

FIGS. 5 a and 5 b are perspective views of prior art anchor devices.

FIGS. 6 and 6 a are a perspective view of a surgical implant constructedin accordance with a preferred embodiment of the present invention foruse in attaching sutures, grafts, tissues and the like to bone,periosteum, and soft tissue, and a side view of the same being insertedinto bone.

FIG. 7 a is a perspective view of a surgical implant constructed inaccordance with a second preferred embodiment of the present inventionfor use in attaching sutures, grafts, tissues and the like to bone,periosteum, and soft tissue. Such figure depicts the surgical implantassuming a pre-insertion configuration.

FIG. 7 b is a perspective view of the surgical implant of FIG. 7 a withthe implant assuming an expanded, anchoring configuration.

FIG. 8 is a perspective view of a surgical implant constructed inaccordance with a third preferred embodiment of the present inventionfor use in attaching sutures, grafts, tissues and the like to bone,periosteum, and soft tissue.

FIG. 9 is a cross-sectional view of the pubic bone and periosteumthereof having an affixation device affixed with the latter, saidaffixation device being constructed in accordance with a fourthpreferred embodiment of the present invention useful for securingsutures, grafts, tissues and the like to bone, periosteum and softtissue.

FIG. 10 is a perspective view of the affixation device depicted in FIG.9.

FIG. 11 is a cross-sectional view of the pubic bone and periosteumformed thereabout having an opposed end of a graft being secured theretowith an implantable tack, the latter being constructed in accordancewith a fifth preferred embodiment of the present invention.

FIG. 12 is a cross-sectional view of the pubic bone and periosteumformed thereabout showing the graft depicted in FIG. 11 being securedthereto via the implantable tack.

FIG. 13 is a frontal view of the graft depicted in FIGS. 11 and 12 assecured to the periosteum via the implantable tack of the presentinvention.

FIG. 14 is a cross-sectional view further depicting an expanded view ofthe pubic bone with periosteum formed thereabout having an opposed endof the surgical sling affixed to the periosteum via a surgical staple,the latter being constructed in accordance with a sixth preferredembodiment of the present invention, the staple assuming a firstinsertion mode.

FIG. 15 is a side-view depicting the surgical staple depicted in FIG. 14securing an opposed end of the sling to the periosteum, the stapleassuming a second, affixation configuration.

FIG. 16 is a cross-sectional view of a suture having a plurality ofaffixation devices secured thereto, the latter constructed in accordancewith a preferred embodiment of the present invention, for use insecuring the suture along a desired pathway through tissue.

FIG. 16 a is a perspective side view of FIG. 16.

FIG. 17 is a frontal, partially cross-sectional view of a sling beingsecured beneath a urethra and selectively secured into position tolayers of muscle/rectus fascia via an anchoring plate fixation device asconstructed in accordance to a preferred embodiment of the presentinvention.

FIGS. 17 a and 17 b are top views of the fixation device utilized inFIG. 17, the fixation device being shown in a first operativeconfiguration in a second locking or closed configuration.

FIG. 18 is a perspective view of an anchoring system constructed inaccordance with another preferred embodiment of the present invention.

FIG. 19 is a perspective view of an anchoring system constructed inaccordance with another preferred embodiment of the present invention.

FIG. 19 a is a partial cross-sectional view of the system depicted inFIG. 19 shown with a suture line extending through a channel definedthereby.

FIG. 19 b is the cross-sectional view of FIG. 19 a wherein the channelof said anchoring system is shown in a crimped configuration, the crimpmaintaining the suture disposed within the channel in fixed position.

FIG. 19 c is a cross-sectional view of the anchoring system depicted inFIG. 19 with one channel extending therethrough, said channel having twosuture lines extended therethrough.

FIG. 20 is a perspective view of a sling deployment system comprised ofa self-anchoring sling member comprised of an elongate sling havinganchoring mechanisms formed on the opposed sides thereof, a respectiveone of the anchoring mechanisms being coupled with a manually operablesling deployment mechanism constructed in accordance with a preferredembodiment of the present invention.

FIG. 20 a is a perspective view of the sling member depicted in FIG. 20.

FIG. 20 b is a perspective view of the sling deployment mechanismdepicted in FIG. 10.

FIG. 21 is a perspective illustration of the sling deployment system andcomponents thereof as depicted in FIGS. 20, 20 a and 20 b wherein arespective anchor mechanism of the sling component is advanced into anincision made in a vaginal wall.

FIG. 22 is a perspective view of the self-anchoring sling depicted inFIGS. 20, 20(a) and 21 as positioned within the obturator canal andoperative to support the patient's urethra.

FIG. 22 a is a perspective view of an embodiment anchoring mechanism asincorporated within the self-anchoring slings of the present inventionas constructed in accordance with a preferred embodiment.

FIG. 22 b is a perspective view of an embodiment anchoring mechanism asincorporated within the self-anchoring slings of the present inventionas constructed in accordance with another preferred embodiment.

FIG. 22 c is a screw-type anchor for use with the self-anchoring slingsof the present invention as constructed in accordance with yet a furtherpreferred embodiment.

DETAILED DESCRIPTION OF THE INVENTION

The detailed description as set forth below in connection with theappended drawings is intended as a description of the presentlypreferred embodiments of the invention, and is not intended to representthe only form in which the present invention may be constructed orutilized. The description sets forth the functions and sequences ofsteps for constructing and operating the invention in connection withthe illustrated embodiments. It is understood, however, that the same orequivalent functions and sequences may be accomplished by differentembodiments and that they are also intended to be encompassed within thescope of this invention.

Referring now to the drawings, and particularly FIGS. 6-15. there areshown various embodiments of the devices and systems of the presentinvention for securing sutures, grafts, tissues and synthetic materials,and the like to bone, periosteum and other soft tissue. As is well knownin the practice of medicine, a wide variety of surgical procedures oftennecessitate the use of anchoring devices for purposes of attachingsuture lines and grafts to bone. Exemplary of such anchoring devicesinclude those disclosed in U.S. Pat. Nos. 5,370,662 and 5,443,482, theteachings of which are expressly incorporated herein by reference asfrequently deployed in orthopedic, gynecologic, and urologic surgicalprocedures.

Among the more well-known surgical procedures incorporating the use ofsuch anchoring devices include transvaginal sling surgery. Asillustrated in FIGS. 1 and 2, such surgical procedure 10 involves theformation of a sling 12, which may comprise a harvested graft from adonor, or the patient's own tissue or an elongate strip of fabricatedsynthetic material or some combination thereof, that is introduced viaan opening made to the vaginal wall 14 selectively positioned beneaththe urethra 16. Once properly positioned, the sling 12 is secured intoposition. Unlike conventional transvaginal sling surgery, however, thesling 12 as depicted in FIGS. 1 and 2 is secured within the retropubicspace via an anchoring mechanism 20, more clearly depicted in FIG. 2. Aswill be appreciated by those skilled in the art, the method by which theopposed ends 12 a, 12 b of the sling 12 are secured, namely to theposterior side of the pubic bone 18, represents a novel approach insofaras such sling 12 is stitched into position in the retropubic space 22,as opposed to the suprapubic space which is conventionally utilized.Unlike alternative methods of performing suburethral sling procedures,such transvaginal sling surgical procedure advantageously dispenses withthe need to form an incision in the patient's lower abdomen 24 to thusenable the surgeon to gain access to the various anatomical structures,such as the abdominal fascia, pubic bone, or Cooper's ligament, to whichthe opposed ends of such sling are to be attached. As is well known,performing such abdominal incision increases operative time, increasesthe chances of infection, delays recovery time, and leaves undesirablescarring. Moreover, such sling procedure as depicted does not requirethat the sutures or opposed ends of the grafts be caused to penetratethrough the intervening pubocervical fascia 28, depicted in FIG. 1,present in the retropubic space 22 which, as will be appreciated bythose skilled in the art, prevents ingrowth of the opposed ends 12 a, 12b of the sling 12 sought to be secured in position.

As a result of the support imparted by the sling 12 to the urethra 16during such times as the patient makes provocative gestures, as occursduring coughing, such sling 12 serves as support that preventsincontinence occurring during such provocative event. To insure that thesling 12 is positioned such that the same imparts an optimal degree ofsupport to the urethra 16, it is contemplated that a tension/pressuremonitor 26, as depicted in FIG. 1, may be utilized during theperformance of such surgical procedure. Such tension/pressure monitors26 may take any of a variety of forms such as those disclosed inApplicant's co-pending U.S. patent application Ser. No. 09/157,466, theteachings of which are expressly incorporated herein by reference.

In order to provide an anchoring mechanism necessary to secure the slinginto position during transvaginal sling procedures, however, there mustbe deployed the aforementioned anchoring device 20. As depicted in FIG.3, there is shown one such anchor deployment device 30, also known inthe practice of medicine as a bone screw inserter, which allows forbone-screw fixation. Perhaps the most well-known of such devices includethe In-Fast and In-Tac bone screw and bone anchor fixation devicespreviously produced by Influence, Inc. of San Francisco, Calif. Suchaffixation devices are formed to have a generally “U” shape as shownthat enables the distal-most end 32 thereof to be easily inserted intothe vagina and be correctly positioned on the posterior portion of thepubic bone. As will be appreciated by those skilled in the art, thedistal-most end 32 of such fixation deployment devices 30 are designedto deploy an anchoring device by screwing or embedding the same intobone at a specific site.

As more clearly seen in FIG. 4, once deployed, the anchor devices 34 areadvanced through the periosteum 36 and become embedded into the bone. Toprovide means for affixing the suture lines or grafts thereto, there istypically formed on the anchor devices a post, hook or eyelet, as shown.Among the more well-known designs of such anchoring devices currently inuse include those depicted in FIGS. 5 a and 5 b. The first such priorart device 34 depicted in FIG. 5 a comprises a self-tapping bone screw40, typically made of titanium, having an eyelet 42 formed thereon towhich the sutures 44 or other material may be attached, as shown in FIG.4. In the alternative prior art configuration 50 depicted in FIG. 5 b,the anchor fixation device comprises an anchor portion 52, which maytake the form of a conical member having a shaft or attachment member 54extending therefrom, the latter being formed to have one or moreapertures 56 thereon to which sutures 58 or other material may beattached. Such devices are typically “shot” into position viaspring-loaded insertion devices, such as the In-Tac device discussedabove.

Although such prior art anchor devices, such as those depicted in FIGS.5 a and 5 b, generally provide sufficient support to the various suturesand grafts affixed thereto, such fixation devices 34, 50 suffer fromnumerous drawbacks. With respect to the bone-screw fixation devices 34,such devices are difficult to deploy and fix into position. In thisregard, such screw fixation devices 34 require the battery-operatedinserters 30 depicted in FIG. 3 that must necessarily drill the fixationdevice 34 into position. Removing such devices 34 is further problematicinsofar as the same must necessarily be unscrewed from their position,which as those skilled in the art will appreciate requires meticulousprecision.

Anchor devices 50 are also problematic insofar as the same are not onlydifficult to deploy, typically via a spring-loaded gun mechanism, butare often times irretrievable once deployed. In this regard, once suchfixation device 50 is sufficiently embedded within the bone, the anchorportion 52 thereof cannot be reversibly extracted from its embeddedposition within the bone. As such, to the extent such anchoring devices50 have been inappropriately deployed (e.g., deployed at a wronglocation), there is little, if any, recourse to retrieve the same.Additionally, such prior art bone screws 34 and anchors 50 have theability to become loosened and dislodged from their position once asufficient amount of pressure is applied thereto over time. Theprobability of becoming dislodged is further increased in thosesituations where a persistent strain is applied to such devices in asingle direction, as can occur when a suture or graft is hung upon theanchoring device. In such circumstances, surgical intervention isnecessary to not only retrieve the dislodged screw or anchor, but alsodeploy yet another of such devices as per the original surgicalprocedure.

Referring now to FIGS. 6-8, there are shown three embodiments 60, 70, 80of a surgical implant insertable into bone (as well as periosteum,ligaments, and other soft tissue) which are useful in providing means tosecure sutures, grafts, tissues, synthetic materials, and the like tobone, as may be necessary for a given surgical procedure. Each of theembodiments depicted have the advantage of being easy to insert andremove, as well as provide an equal, if not greater, degree of supportthan prior art devices. Such novel implants further have the ability toremain more firmly seated into position once embedded in bone than suchprior art devices.

Referring now to FIG. 6, there is shown a first embodiment 60 of thesurgical implant. As illustrated, the implant 60 comprises a pitonmember 62 having an eyelet 64 formed thereon. The piton member 62preferably comprises an arcuate blade having proximal and distal ends,the latter being designed to be inserted into bone such that as the sameis advanced therein, there is defined a penetration pathway as indicatedby the latter “A”. Once inserted into the bone tissue at the target siteof fixation, the eyelet portion 64 of the implant will extend therefromas illustrated in FIG. 6 a, which will thus provide the necessarystructure to which the sutures 66, grafts and the like may be attached.Although the embodiment shown depicts the use of an eyelet 64, it willbe recognized that other substitute support or attachment structures,such as posts, hooks and the like, including even sledged-on fixation ofthe suture or graft to the piton, may be utilized as may be necessaryfor a given application.

As will be appreciated by those skilled in the art, by inserting theimplant in the direction indicated by the letter “A”, it will beappreciated that to the extent a force is applied thereto, such as bysuture 60 or graft, via a vector having an orientation in the generaldirection of letter “B”, such force will necessarily cause the implantto wedge deeper and become more secure into position within the bone 38,and will thus cause the same to become more rigidly affixed intoposition unlike prior art devices which have a tendency to become looseand potentially dislodged with the application of greater amounts ofpressure and strain thereto.

Such implant further provides the advantage of being easy to remove. Inthis regard, due to its orientation within the bone, to the extent apulling force is applied to the implant in the direction indicated bythe letter “C”, such implant 60 will be caused to become easilydislodged from its seated position to the extent it becomes necessary toremove and/or reposition such implantable fixation device. Such ease ofremoval advantageously provides for a simpler, less traumatic procedurethan those procedures involving prior art screw and anchor fixationdevices.

Referring now to FIGS. 7 a and 7 b, there is shown a second embodiment70 of a surgical implant designed to be embedded within bone or softtissue to which may be attached sutures, grafts and the like. Suchembodiment 50, similar to the embodiment 60 depicted in FIG. 6, isspecifically designed such that the same becomes more firmly seated intoposition within the bone to the extent a force is applied in a firstdirection, as indicated by the letter “D”. FIG. 7 a depicts the surgicalimplant 70 assuming an insertion configuration which enables the same tobe implanted into bone at a target site selected by the surgeon. Suchimplant is provided with a piton member 72 having opposed flanges 72 a,72 b formed at the distal end thereof that are designed to spread apartin the directions “Y” and “Z” and become more deeply embedded within thebone to the extent a pressure is applied in a direction indicated by theletter “D”. Although the specific embodiment 70 shown depicts that theopposed flanges 72 a, 72 b flare outwardly, it is to be understood thatsuch flanges can be designed to curve inwardly. Moreover, although suchembodiment depicts two opposed flanges, it should be recognized thatsuch implant may have three or more flanges and that each respectiveflange may be designed to flare outwardly, as shown, or hook inwardly asmay be needed to a specific application.

Once firmly embedded within the bone, the eyelet portion 74 of suchimplant may be utilized to attach sutures and the like. Of additionaladvantage, similar to the embodiment shown in FIG. 6, is the fact thatsuch implant 70 may further be easily removed to the extent a pulling oropposed force is applied in the direction indicated by the letter “E”.As such, to the extent it becomes necessary to remove or otherwisereposition such anchoring device, such anchoring device 70 may be easilydislodged by application of such force. As will be appreciated, suchdesign allows for easier and less traumatic removal than prior artanchor and screw fixation devices.

Referring now to FIG. 8, there is shown a third embodiment 80 of asurgical tissue implant useful as a fixation device to attach sutures,tissues, and grafts to bone, periosteum, and soft tissue. As per theother embodiments, such implant 80 includes a piton member 82,preferably formed as a sickle-shaped member, having an eyelet 84 formedon the proximal end thereof. Such implant 80 is designed to be embeddedinto the bone or other tissue in the direction indicated by the letter“F”. Once so secured into position, forces may be applied thereto, viaeyelet 84 in the direction indicate by the letter “G”, which will thuswork to further embed the piton member 82 into the bone via thepenetration pathway defined by the distal end of the piton member 82 sothat the implant becomes more secure therewithin. Likewise, to theextent it becomes necessary to remove such device 80, such device may beremoved by pulling or otherwise rearwardly retracting the implant in thedirection indicated by the letter “H” which, as discussed in the otherembodiments, provides for simpler and less traumatic procedure thanprior art methodology.

Although each of the aforementioned embodiments 60, 70, 80 areparticularly well-suited for insertion into bone, it should berecognized by those skilled in the art that the same may be utilized toaffix sutures, grafts, tissues, synthetic materials and the like toconnective tissue, and in particular, periosteum as per the furtherembodiments discussed more fully below. In this respect, each of theaforementioned embodiments 60, 70, 80 may be designed such that thepiton portion thereof pierces into and becomes embedded within suchtissue and remains firmly seated thereat so that the attachmentmechanism formed thereon can provide a service to which the sutures,grafts and the like may be attached.

As will further be appreciated, in each of the embodiments 60, 70, 80depicted in FIGS. 6-8, the orientation of each of the implants as thesame are embedded into the bone or tissue is crucial for the necessaryoperation thereof. In this regard, it will be appreciated that theimplant must be oriented such that the resultant tension or strainapplied thereto will cause the piton portion thereof to advance in thepenetration pathway defined thereby. Otherwise, to the extent tension isapplied in an opposed direction, such implant may be caused to dislodgefrom its seated position. As a consequence, it will be appreciated thatthe implants of the present invention must be selectively positioned,and that the surgeon must take great care in making certain that theultimate tension applied thereto is oriented to facilitate theattachment of the implant to the bone, as opposed to casing the same tobecome dislodged therefrom.

Referring now to drawings 16 and 16 a, there is shown an additionalsurgical tissue implant 500 useful as a fixation mechanism to attachsutures, tissues, and grafts to soft tissue. In the embodiment depicted,which is shown being deployed for use in securing a sling 502 intoposition to provide support to a urethra 504, the implant 500 comprisesa plurality of dual-prong anchoring mechanisms 506 disposed linearlyabout a suture-like cord or line 508, which enables such line to advancethrough the tissue in one direction, but resists rearward movement inthe opposite direction. As shown, the implants can be configured to havea generally V-orientation such that the suture 508 bisects such implantand extends therethrough. As will be recognized, each respective implantwill have an eyelet or other aperture through which the suture, whichmay be a suture line or suture-like cord, may be extended. As will befurther recognized, although depicted as having a generallyV-orientation, it will be appreciated that the anchoring mechanisms 506may be arranged in a staggered configuration, extend along only one sideof the suture 508, or otherwise be radially disposed about a length ofthe suture 508. Accordingly, it will be recognized that numerous otherdesigns are contemplated that fall within the scope of the presentinvention.

By linearly disposing the implants along the suture line, the sutureline may be advanced in a direction indicated by the letter “X”, but yetresist movement in the direction indicated by the letter “Y”.Advantageously, such arrangement enables the suture line 508 to bepulled into a desired position such that the sling 502 supported therebycan be caused to provide a selective degree of support to the urethra504 or otherwise maintain a desired distance therefrom. Furthermore, tothe extent the suture line 508 with implants 506 or the sling 502supported thereby are inappropriately positioned, it will be recognizedby those skilled in the art that, if necessary, the suture line 508 canbe cut and the suture with implants affixed thereto extracted completelyfrom the patient's body (and replaced, if necessary or desired). Suchdesign further advantageously permits for the adjustment of the sutureline and/or the sling supported thereby not only intro-operatively, butalso post-operatively insofar as the suture line 508 can be extendedfurther, for example, in the direction indicated by the letter “X”, asmay be desired to the extent it is necessary to add extra tension to thesuture line 508. Moreover, as discussed above, the suture line 508 canbe removed entirely from a patient's body. In such circumstances, asecond suture line 508 having such implants attached can be substitutedin its place.

An example of the application of such system is illustrated in theside-perspective view of FIG. 16 a. As illustrated, the sling 502 ispositioned about the urethra 504 and supported upwardly by thesuture-like cord 508 having the fixation devices 506 linearly disposedupon the length thereof. In this regard, each respective suture, cord,etc. 508 supporting each respective side of the sling 502 may beselectively caused to remain securely embedded at a desired positionwithin the rectus fascia 510 or other soft tissue. As will beappreciated by those skilled in the art, due to the ability of thesuture lines or suture-like cords 508 with the novel implant fixationdevices 506 affixed thereto, the surgeon can incrementally increase thepressure exerted by the sling 502 against the urethra 504 or thedistance by which the sling 502 extends from the urethra 504 merely byincrementally advancing the suture line/cord 508 through the rectusfascia 510. As will be appreciated, there has not heretofore beenavailable any mechanism available which provides a surgeon with theability to merely advance a suture through tissue and have the sameremain firmly secured into position. Rather, and as discussed more fullyin the background, surgeons have had to identify a target site to whichsuch sling can be anchored and thereafter tie the same into positionsuch that the sling maintains the desired degree of support or distancefrom the urethra. As is widely recognized, malposition of the sling hasbeen deemed the cause for creating a significant problem andsubstantially high morbidity for those patients having undergone slingsurgery.

In a similar, yet further advanced variation of the embodiment depictedin FIGS. 16 and 16 a, there is shown in FIGS. 20-22 c a system 800comprised of the combination of a deployment mechanism 804 and surgicalimplant 802, the latter being configured as per tissue implant 500 thatenables a sling portion 806 to be secured into position via the use ofanchor mechanisms 808 a, 808 b, the latter of which are operative toadvance through tissue in one direction but resist rearward movement inan opposite direction. In this regard, and as more clearly depicted inFIG. 20 a, implant 802 will preferably be comprised of an elongate slingportion 806, which as those skilled in the art will appreciate may takeany of a variety of natural tissues, synthetic material or somecombination thereof operative to become implanted within the body andsupport a specified anatomical structure. Affixed on the opposed ends ofthe sling 806 are dedicated anchor mechanisms 808 a, 808 b which areaffixed to the respective ends of the sling 806 via a coupling apparatus810, which may likewise comprise any of a variety of attachmentmechanisms known in the art.

Each respective anchor mechanism 808 a, 808 b may be configured per avariety of embodiments, discussed more fully below, that can enable eachmechanism to be advanced into a target site of tissue in one directionyet resist movement when pulled in an opposed direction. In this regard,each respective anchor mechanism 808 a, 808 b, will be preferably formedupon the opposed ends of the sling 806 such that the anchor mechanisms808 a, 808 b can be advanced through a target site of tissue indissimilar directions, such as opposed directions, to thus enable thesling 806 a to stretch beneath and ultimately support the targetanatomical structure as previously discussed above with reference toFIGS. 1 and 16 (as well as FIG. 22 more fully below). To achieve thatend, anchor mechanisms 808 a, 808 b may be provided with generallyarrowhead-shaped members, V-shaped members, Y-shaped members, or anystructure well-known in the art that facilitates the ability of theanchor mechanisms 808 a, 808 b to cut through and become positioned orembedded within a target site of tissue such that the same can becomeresident or fixed in position. In this regard, it is contemplated thatthe anchor mechanisms 808 a, 808 b, may be provided with a texturedsurface or otherwise be provided with materials to facilitate theingrowth of tissue about the same to thus enable the anchor mechanismsto remain firmly seated into position once implanted into the body.Illustrative of such an embodiment would include the use of a meshmaterial cut such that the strands of the fabric of such mesh facilitatemovement when advanced in a first direction but resist rearward movementdue to the frayed, outwardly-flaring strands of the mesh that would beoriented to cause such loose ends to resist or become biased againstrearward movement.

To facilitate the ability of the implant 802 to be accurately andsecurely placed into position within the body, a deployment mechanism804, more clearly depicted in FIG. 20 b, may be utilized. Although theimplant 802 may be surgically implanted into position utilizing avariety of well-known surgical techniques, it is believed thatdeployment mechanism 804 may be useful to more quickly, accurately andatraumatically position and securely affix such implant 802 intoposition. As illustrated, the mechanism 804 comprises a manuallyoperable handle 812 having a deployment member 818 extending distallytherefrom. An actuator mechanism 814 is disposed within the handle 812and includes an elongate shaft portion 816 disposed axially within thedeployment member 818 such that the distal-most end thereof 816 a iscaused to selectively protrude through a distal-most opening 818 a ofthe deployment member 818. The actuator 814, and more particularly theshaft 816 thereof may be selectively coupled to an anchor mechanism suchas 808 a depicted in FIG. 20 to thus direct and position the anchormechanism 808 a at a target site within the body. Such deployment member818 may be configured to have a variety of sizes and shapes, and may bespecifically configured for deployment of an implant 802 at a particulartarget site within the body. For use in deploying implants, such as 802,to provide suburethral support for the treatment of incontinence, it iscontemplated that the deployment member 818 will have a generallyarcuate shape and may further be preferably configured to deploy theimplant 802 within the obturator canal of a patient via atrans-obturator route, discussed more fully below.

To facilitate the interconnection between the implant 802, and moreparticularly an anchor mechanism 808 thereof, with the deploymentmechanism 804, it is contemplated that such anchor mechanism 808 may bepre-loaded in a cartridge, not shown, the latter being selectivelyinterconnectable with the deployment member 818. In such embodiment, itis contemplated that such cartridge will be operative to form a rigidcasing about the anchor mechanism 808 to thus enable the anchormechanism to be easily affixed into position on the deployment member818 and thereafter surgically guided into position such that once atarget site has been accessed, the anchor mechanism 808 can beselectively deployed from the cartridge. To help enable the cartridge toreach such desired target site, it is contemplated that such cartridgemay be provided with a cutting apparatus or sharpened cutting edge tothus enable the same to cut and advance through tissue. To that end, itwill be readily appreciated by those skilled in the art that manypossible designs and configurations will be readily apparent toeffectuate that end.

Referring now to FIG. 21, there is shown the use of the system 800 todeploy the implant 802 via the deployment mechanism 804. In theprocedure illustrated, such implant 802 is being deployed through anincision 822 formed within the vaginal wall 820 to thus enable a urethra824 to ultimately become supported thereby. In this regard, theprocedure depicted in FIG. 21 represents deployment of a suburethralsling via a trans-obturator route. As is well-known, most slings arecurrently delivered via a retropubic route, and although the implants802 and deployment mechanisms 804 can readily be adapted and utilizedfor such procedures, current methodology suggests that implant or slingdeployment made via a trans-obtruator route substantially minimizeswell-known risks associated with bleeding and/or intestinal or bladderinjury associated with surgical sling implant procedures utilizing aretropubic route to gain access to the surgical site. In this regard,current medical literature strongly suggests that a trans-obturatorroute substantially avoids the blood vessels existing within and abovethe pubocervical fascia, bladder and the intestines. Moreover, securingslings into position according to conventional methodology utilizingretropubic access often times results in sling dislodgement ormisplacement, especially so when conventional sling anchoring fails dueto the pull or dislodgement of anchors and/or mesh when the patientengages in a violent provocative event, such as coughing, vomiting orsome other violent activity.

As shown, the deployment mechanism 804 is selectively positioned suchthat an anchor mechanism 808 a of the sling is advanced into theincision 822 via distally-extending deployment member 818. The actuator814, and more particularly the shaft 816 extending therefrom, isoperative to advance the anchor member 808 a away from the distal end818 a of the member and through the soft tissue until the same becomeswithin a target site of tissue. To facilitate the ability of themechanism to gain access to the target site, it is contemplated that thedistal-most end 818 a of deployment member 818 may be provided with asharpened cutting surface to thus enable the same to be advanced throughtissue, along with anchor mechanism 808 a to thus enable the implant tobe positioned with only one percutaneous incision 822 made in thevaginal wall 820. Along these lines, it is contemplated that once ananchor mechanism 808 a is sufficiently positioned, the second anchormechanism 808 b will be affixed to the distal-most end of the deploymentmember 818 of mechanism 804 and likewise be secured into position byselectively advancing the anchor mechanism 808 b through the sameincision but in an opposed direction relative the first anchor mechanism808 a, the latter having been secured into position and thus operativeto resist rearward movement.

As will be readily appreciated by those skilled in the art, by merelyadvancing the anchor mechanisms 808 a, 808 b, in generally opposeddirections, the anchor mechanisms will thus be operative to stretch outthe sling portion 806 such that the same can selectively and accuratelybe positioned about a target anatomical structure. In this respect, itis contemplated that the sling portion 806 can be positioned such thatthe same maintains a specified degree of tension or support to ananatomical structure, such as the urethra 824, or may otherwise bepositioned such that the same maintains a desired spatial relationshipand orientation relative an anatomical structure. Of additionaladvantage is the fact that each respective opposed anchor mechanism 808of the implant 802 can be positioned within the body via a singleincision or point of access, which thus eliminates the need for a secondincision or access point to be formed in the body, as is known perconventional sling placement which typically requires that separateaccess points or incisions be made for each fixation point, (i.e., thepoints at which the opposed ends of the sling are fixed into positionwithin the body).

As a consequence, and shown more clearly in FIG. 22, the implant 802 maybe selectively positioned such that the sling 806 component thereofproperly supports the urethra 824 as is desired to achieve a favorableoutcome. In the placement of the implant 802 as depicted, however, thesame illustrates the fixation of the implant 802, and more particularlythe sling 806 thereof, within the obturator canal of pelvis 830, asdefined by the pubis 834 and ishium 832 regions thereof. In this regard,each respective anchor mechanism 808 a, 808 b becomes embedded within atarget tissue site, such as the pubocervical fascia, toward or throughthe obturator canal and ultimately positioned in the desired localerelative the bladder 828 and, more particularly, urethra 824 extendingtherefrom.

As discussed above, anchor mechanisms 808 a, 808 b will preferably beformed or attached to the opposed ends of the sling 806 to thus enablethe opposed ends to be stretched out and positioned in the desiredmanner. To achieve that end, it is important that the anchor mechanisms808 a, 808 b be configured to thus enable the same the be easilyadvanced into position, to thus achieve the desired goal of fast,accurate and atraumatic placement, but at the same time provide thenecessary degree of anchoring support to thus define a secured point offixation from which the sling 806 can extend and ultimately impart thedesired degree of support. FIGS. 22 a-22 c depict various embodiments ofthe anchor mechanism 808 that are contemplated to achieve thoseobjectives.

Referring now to FIG. 22 a, there is shown an enlarged view of an anchormechanism 808 similar to that depicted in FIG. 22. As illustrated, theanchor mechanism comprises a plurality of anchor bodies 840 each havingopposed, outwardly extending anchor members or arms 842 which thusdefine a generally Y-shaped body. Each respective anchor mechanism 840is disposed upon elongate cord 844, which may take the form of a sutureor other implantable material well-known to those skilled in the art.

FIG. 22 b represents a similar embodiment whereby a plurality ofgenerally chevron-shaped anchor members 850 are disposed upon the lengthof an elongate cord 854. Each respective chevron-shaped member 850 isprovided with outwardly-extending members or arms 852 that provide ameans to anchor the same into tissue. Both the embodiments depicted inFIGS. 22 a and 22 b, similar to those discussed above in relation to theembodiment depicted in FIGS. 16 and 16 a, essentially comprise aplurality of dual-pronged anchor mechanisms disposed linearly about acord-like suture of various malleability to thus enable the same toadvance through tissue in one direction, either by pushing or pulling,but resist rearward movement in an opposite direction. In this respect,the generally Y-shaped and generally chevron-shaped embodiments depictedin FIGS. 22 a and 22 b are similar to the generally V-orientedembodiment depicted in FIGS. 16 and 16 a to thus enable a plurality ofanchoring members to be disposed upon a length of cord, suture and thelike, to be linearly disposed there along. It will be recognized,however, that numerous other designs are contemplated that fall withinthe scope of the present invention. As discussed above, such anchormechanism may comprise selectively oriented segments of mesh materialthat are selectively oriented such that the loose or frayed fiber endsof the mesh extend in a rearward configuration to thus resist rearwardmovement.

Referring now to FIG. 22 c, there is shown a similar type embodimentwhereby the anchor mechanism 808 is defined by a screw mechanism 862,having a distal-most end 860 operative to advance into tissue along acentral axis 864, the latter of which may be a cord or cable having arequisite stiffness. Alternatively, screw mechanism 862 and central axis864 may comprise a firm yet malleable material suitable for implantationwithin the body. In such embodiment, it is contemplated that thescrew-anchor mechanism 862 can be advanced into a target site of tissueby either blunt advancement or rotational advancement, the latter beingfacilitated by use of a deployment system 804 whereby the deploymentmember 818 is operative to selectively position the same within a tissuemass.

As will be appreciated, alternative anchoring mechanisms arecontemplated and will be readily known to those skilled in the art.Along these lines, it is contemplated that the anchor mechanisms may beformed to be operatively transitional between a first compressed statewhereby one or more of the anchor members, and more particularly theoutwardly extending prongs thereof as depicted in FIGS. 22 a, 22 b areadvanced into position within a target site of soft tissue and a secondoperative configuration whereby the anchor members and/or prongs thereofexpand to become fixed into position at the appropriate target site ofsoft tissue.

Although not shown, in order to achieve such selective placement of theanchoring mechanisms capable of operatively transitioning between suchfirst and second configurations, it is contemplated that such anchormechanisms may be selectively positioned via the use of conventionaldeployment techniques and devices, such as catheters, needles, and/orguide wires. Exemplary of the latter, as utilized to position suchoperatively transitional anchor mechanisms for use in sling surgery,would be accomplished via the introduction of the guide wire through andthen under the vaginal wall. Once properly positioned, an expansion isthen effectuated along the guide wire, via the use of conventionalcoaxial or balloon systems or other well-known spreading devices that,following deployment, are thereafter removed. As per the proceduresdiscussed above, it is understood that once a first anchor mechanism isdeployed, a similar procedure must necessarily be followed to deploy thesecond respective anchor mechanism such that the sling disposedtherebetween is operatively positioned to impart the desired support orpositioning at a specified anatomical site.

Another example for use in deploying such operatively transitionalanchor mechanisms would include the use of an elongate sheath that isfocused as a portion of the deployment member 818 is operative to retaina multiplicity of anchor mechanisms, and in particular a plurality ofanchor bodies, such as 840 depicted in FIG. 2, within an elongate lumenthereof. It is contemplated that such sheath will have a sharpeneddistal end to thus enable the same with anchor bodies retained thereinto be selectively positioned such that the prongs or other attachmentelements thereof do not cut, engage with or otherwise become prematurelydeployed. Along these lines, it is contemplated that such sheathdeployment member would ideally be utilized to selectively position amultiplicity of anchor members positioned along a suture line or othercord-like structure, and may further include mechanisms to facilitatethe deployment of such anchor mechanisms to either extend from or bewithdrawn within the lumen of such sheath. It is likewise contemplatedthat such sheath can be used to deploy a plurality of linearly-arrangedradio opaque markers, such as the TINED lead system of radio opaquemarkers produced by Medtronics, Inc. which have a configuration similarto that of the anchor bodies depicted in FIG. 22A. In use, it iscontemplated that such sheath may be provided with an elongate slotformed along a portion the length thereof that enables the cord-likestructure having one or more anchor mechanisms formed thereon to bepulled or pushed into the sheath as well as allow the sheath to beremoved following the placement of the anchor mechanism deployedthereby.

Referring now to FIG. 17, there is shown yet another embodiment of adevice 600 for attaching sutures, grafts, tissues and the like intoposition in the human body. As illustrated, such embodiment comprises ananchoring disc or plate 602 which may be secured to or rest upon ananatomical structure, and more particularly a layer of muscle 604 orrectus fascia 606 as shown. As illustrated, which again is in thecontext of securing a sling 502 into position such that the urethra 504is supported thereby, suture lines or suture-like cords 508 on eachopposed end of the sling 502 are secured by dedicated anchoring plates602, the latter being supported by a layer of muscle and/or layer ofrectus fascia. As shown, the anchoring plates 602 are operative tosecure the suture lines 508 into position such that the same are allowedto selectively advance therethrough and remain secured in positionthereby without requiring that the sutures 508 be ties (i.e., at thefascia level 606).

To achieve that objective, there is shown in FIGS. 17 a and 17 b themechanism by which the anchoring plate 602 is operative to secure thesuture lines 508 thereto. As shown in 17 a, the anchoring plate 602comprises the combination of a first inner plate member 610 having atleast one, and preferably two diametrically opposed apertures 612 formedtherein. Encased about the first plate member 610 is a second annularplate member 614 which also includes at least one, and preferably two,apertures 616 formed therein, such apertures 616 being selectivelyalignable with the apertures 612 formed upon the first inner plate 610.The first inner plate member 610 is rotationally mounted within theouter anchoring plate member 614, such that the same is operative totransition between a first open configuration, wherein the apertures 612of the first inner plate 610 are alignable with those formed on theouter annular plate 614, and a second closed configuration, as shown inFIG. 17 b, wherein the apertures formed on the inner and outer plates612, 615, respectively, are not aligned with one another, such that aclosure is formed.

In use, the anchoring plate 602 may be secured into position, via prongsor some other type of anchoring mechanism (not shown) to a desired site.Alternatively, it will be appreciated that such anchoring plate 602 mayonly need be placed on the rectus fascia and, as discussed more fullybelow, due to the downward force exerted upon the anchoring plate 602via the sutures held thereby, such anchoring plate will be caused toremain resident at the desired deployment site. Once positioned, theinner and outer plate members 610, 614 are maintained in the firstoperative configuration such that the apertures 612, 616, respectivelyformed thereon form the opening or openings through such anchoring plate602. The suture lines 508 may then be extended through apertures definedby the first and second plate members such that the sling 502 heldthereby is maintained in a desired orientation or provides a desireddegree of support to the urethra 504. Once so positioned, the inner andouter plate members 610, 614 are rotated relative one another such thatsecond closed configuration is maintained, which thus serves to securethe suture lines 508 into position. To facilitate that end, a knob 618or other turning mechanism formed upon the inner plate may be providedto facilitate the insertionability to secure the suture lines 508 intoposition. As discussed above, such design advantageously dispenses withthe need to tie down the suture lines or cords at the fascia level. Tothe extent desired, such anchoring system further enables the suturelines, and more particularly the suture lines extending through theanchor plate, to be secured to one another to thus form a suture“bridge”. As shown in phantom, each respective suture line extendingthrough the anchor plate can be linked to one another as shown. Toachieve that end, it will be appreciated that such suture lines may beeither tied, fused, crimped, linked or joined to one another via any ofa wide variety of methods and devices well known to those skilled in theart.

Referring now to FIG. 18, there is shown a further refinement of thesystem utilized to secure a suture line at a desired location such thata sling, graft or other object supported thereby is maintained at adesired location. As illustrated, such system 640 comprises thecombination of a suture-like cord 642 having a plurality ofprotuberances 644 formed therealong and an anchoring plate 646. Thesuture-like cord 642 with protuberances 644 is formed such that the sameis extensible through tissue. As will be appreciated by those skilled inthe art, attached to an opposed end of such suture-like cord 642 withprotuberances 644 is a graft, sling 502 or some other object to be heldthereby. The suture-like cord 642 is extensible through the anchoringplate 646, the latter being secured at a desired target site, which mayinclude a bone, periosteum, soft tissue, or a layer of rectus fascia 606as shown. The suture 642 is extensible through such anchoring plates 646such that respective ones of the protuberances 644 engage with a lockingaperture 648 formed on such plate 646. As illustrated, each respectiveprotuberance 644 can be pulled through such aperture 648 and thereaftercaused to lock the suture 642 into position. As will be appreciated, asthe sutures 642 pull through the anchoring plate 646, the suture line642 will become progressively shorter and thus raise the object (i.e.,sling 502) held thereby to the desired location. Advantageously, suchsystem accommodated movement in both directions, and by pulling thesuture in the rearward direction can cause the suture to experience anincrease in slack, which thus consequently can lower or lessen thetension in the object supported thereby. As per the embodiment depictedin FIG. 17, these suture-like cords with protuberances, to the extentmultiple cords are utilized, may be linked to one another to thus form asuture bridge, as may be desired for certain applications.

Referring now to FIGS. 19-19 c, and initially to FIG. 19, there is shownan additional embodiment 700 of an anchoring system for securing asuture-like cord or line 508 at a desired location. As per theembodiments depicted in FIGS. 17 and 18, the embodiment shown includesan anchor plate 702 having at least one, and preferably two to four,channels 704 extending therethrough for receiving suture-like cords 508.As per the aforementioned embodiments, the anchor plate 702 may likewisebe secured into position with a fastener mechanism or, alternatively,merely be positioned at a desired site upon fascia or soft tissue withthe ultimate tension imparted thereto by the sutures 508 held therebycausing the same to remain resident at such site. As to the embodimentshown, the anchoring plate 702, once positioned, is operative to receivethe suture line or lines 508 through the channels 704 defined thereby.As more clearly illustrated in the cross-sectional view of FIG. 19 a,the suture-like cord 508 can be pulled upwardly or downwardly until thesame attains the desired position and/or imparts the desired tension toan object held thereby. Once such proper position and/or tension isattained, the channel 704 within which the suture-like cord 508 isdisposed may be crimped, as depicted in FIG. 19 b, such that the sutureline 508 is compressively held thereby. As will be appreciated by thoseskilled in the art, the channel 704 defined by the anchor plate 702 willbe formed from a suitable deformable material well-known to thoseskilled in the art which can not only be easily crimped, but once socrimped, will impart the necessary compressive force to hold the suture508 in position. It will likewise be recognized that the crimp made tothe channel 704 may be formed by any of a variety of surgical crimpingmechanisms well-known and commercially available.

In an alternative configuration depicted in FIG. 19 c, the anchor plate710 is designed such that the same only has one channel 712 formedtherethrough through which one or more suture-like cords 508 may bereceived. As may be desired for certain procedures, particularly whereit is advantageous to simplify such procedures, the channel 712 definedin the anchor plate 710 will preferably be centrally disposed upon theanchor plate such that the same is adapted to receive multiplesuture-like cords therethrough (e.g., four (4) suture lines toaccommodate two (2) opposed ends of a sling). Once the cord or cords 508have been received therethrough and optimally positioned, the channel712 may be crimped such that the cords are compressively held asdesired. Any length of the sutures extending therethrough may be linkedor connected to one another to thus form a suture bridge, which is againin phantom in FIG. 19.

As will be recognized by those skilled in the art, by providing such asimplistic, atraumatic mechanism for securing sutures, grafts and thelike into position substantially reduces suture erosion, greatlyminimizes operative time, patient recovery time and further minimizesthe risk of infection by minimizing the degree of invasiveness typicallyassociated with securing slings and the like into an optimal position.

As will further be readily appreciated by those skilled in the art, theaforementioned anchoring systems, particularly those mechanisms depictedin FIGS. 17-19 c, such may be formed from a bio-absorbable material,such that the anchoring system becomes absorbed over time. As will beappreciated by those skilled in the art, to the extent the anchoringsystem is fabricated to become absorbed over time, the aforementioneddiscussion regarding the suture bridge may be deemed optimal should itbecome necessary to maintain the suture lines at a desired locationfollowing absorption of such anchoring system.

Alternatively, the anchoring systems may be formed from a non-absorbablematerial such that the same remains permanently embedded within thebody. Moreover, it will be recognized that those mechanisms depicted inFIGS. 17-19 c may further incorporate a tension spreading mechanism,such a washer or mesh of fabric, that may be deployed with or integratedas part of such anchoring system. In this respect, it will beappreciated that due to the fact that the suture holding mechanismsdepicted in FIGS. 17-19 c will necessarily have a stress and strainimparted thereto via the sutures held thereby, such plate may dissipatethe stress and strain over a larger surface area via the incorporationof such tension spreading mechanism. As per the anchor platesthemselves, such tension spreading mechanism may be formed from anabsorbable or non-absorbable material and may be formed integral with orseparate from the anchor plate.

Referring now to remaining drawings 9-15, and initially to FIG. 9, thereare depicted further embodiments of the present invention that aredirected to devices for attaching sutures, grafts, tissues and the liketo periosteum 36 (i.e., the thick fibrous membrane covering the surfaceof bones), as well as other types of soft tissue. In this regard, eachof the embodiments herein preferably do not penetrate or otherwisebecome embedded within the bone 38, but rather are attachable to theperiosteum 36 at a specific site thereof. However, it should beexpressly understood that such embodiments may be modified or otherwiseadapted to penetrate and become embedded within the bone 38, as may benecessary or ideal for a given medical procedure.

As will be appreciated by those skilled in the art, a wide variety ofsurgical procedures requiring fixation of sutures, grafts and the like,such as transvaginal sling surgery, particularly when performed inaccordance with the procedure depicted in FIGS. 1 and 2, frequently donot necessitate the use of devices, such as those depicted in FIG. 5,that must necessarily be screwed or anchored within the bone. Quiteunexpectedly, it has recently been reported at a meeting sponsored bythe American Uro-Gynecologic Society that by utilizing the periosteum 36as a point of affixation, such affixation can be made more or equallysecure than prior art bone screws and anchors, but at the same timeachieving satisfactory, if not superior, structural support. In thisregard, deployment of such prior art bone-screw/anchor devices isgenerally considered an excessive measure insofar as such devices areknown to frequently provide an excess amount of support than what istypically required or suitable for such particular purpose. However, dueto the fact that no feasible alternative had been available until now,such bone screw and anchor devices are utilized, which can substantiallycomplicate such surgical procedures as well as cause the patient toendure unnecessary trauma, possibly delayed recovery time, and possiblyhigher risk of infection.

In the first of such embodiments depicted in FIGS. 9 and 10, there isprovided an affixation device 90 comprised of at least one, andpreferably a multiplicity of piton members 92 mounted upon a basemember. Each one of the multiplicity of pitons 92, which may take theform of a hook as shown, is designed to ensnare with and become embeddedin a target site of soft tissue of the periosteum 36, as depicted inFIG. 9, but not penetrate or otherwise disrupt the outer surface of thebone 38 therebeneath. In this respect, the piton members 92 may bedesigned such that with light pressure the same only penetrate within acertain limited depth of the periosteum 36 or tissue, such that the sameprovide a moderate degree of fixation and can be easily removed, or withgreater pressure the same penetrate deeper so that the device 90 canbecome more securely embedded within the periosteum 36 or tissue to thusprovide for a more secure base or attachment. Formed on the base member94 is an attachment means, which may comprise a post or eyelet 96 asshown, to which may be attached the suture 98 or graft. As will beappreciated, the affixation device 90 need only be placed against theperiosteum 36 at a target location such that the piton members 92thereof become embedded there within. Because the piton members 92 ofthe affixation device are caused to only become embedded within theperiosteum 36, such novel fixation device may be easily removed andrepositioned as may be necessary in a given surgical procedure to insurethat an optimal degree of support or positioning is attained.

Once so optimally positioned, the suture 98 or graft may be attached tothe device 90 as per conventional surgical procedures. Alternatively,due to the ease by which the affixation device 90 may be detached andreattached, the surgeon is provided with the option of securing thesuture 98 or graft to such affixation device 90 and thereafterpositioning the affixation device 90 at a target site for bestpositioning. Advantageously, although the affixation device 90 isspecifically designed to provide for easy dislodgment and repositioning,it is believed that once the same is secured into position, due to theeventual overgrowth of tissue about such device 90, the affixationdevice will continue to provide firmer and stronger support over time.

Referring not to FIGS. 11-13, there is shown another embodiment 100 ofan affixation device useful in the attachment of sutures, grafts,tissues and the like to periosteum, soft tissue, and bone. In theembodiment shown, such affixation device 100 comprises a tack memberhaving a hub portion 102 and at least one, and preferably two or more,prong members 104 formed thereon. As illustrated, the implantable tack100 may be utilized to affix a graft 106 or other like tissue to theperiosteum 36 by merely interposing the graft 106 between the periosteumand the tack 100 and compressing such tack 100 there against such thatthe prongs 104 thereof extend therethrough and become embedded in theperiosteum 36 as systematically shown in FIGS. 11 and 12.

As will be recognized, the prong portions 104 of such tack 100 will bespecifically designed and configured to extend through a given layer oftissue or graft material 106 and become embedded into the periosteum 36,but not otherwise extend to or penetrate the bone 38 lying therebeneath(although the embodiment may be modified for such applications). It willfurther be appreciated that such prongs 104 may vary in number and maytake any of a variety of shapes and configurations necessary to achievethat end. As discussed above, it is contemplated that the prong members104 may be designed to penetrate within the soft tissue, periosteum 36,or even bone 38 at specified depths to thus provide for selectivedegrees of attachment thereto. In this regard, it is specificallycontemplated that such prong members 104 may be formed to have astraight, hook or arcuate shape such that the same facilitate theaffixation of a graft 106 to the target site of fixation. For example,in FIG. 12 it will be recognized that due to the arcuate shape of theprong members 104 of the implantable tack 100, when a force is appliedin a direction indicated by the letter “I”, such force will actuallycause the prong members 104 of such implantable tack 100 to penetratefurther within the periosteum 36 to thus cause the affixation to becomemore secure with increased tension. Furthermore, by utilizing a hubmember 102 as part of the implantable tack 100, as illustrated in FIG.13, such implantable tack 100 can be easily accessed and removed inlater surgical procedures. To facilitate such removal, a grip,protrusion or an aperture formed upon the hub may be provided. Forexample, it is contemplated that an attachment material, such as asynthetic mesh “extension” or sleeve, may be formed upon the hub 102.

Referring now to FIGS. 14 and 15, there is shown yet another preferredembodiment 110 of the present invention that comprises a novel surgicalstaple for securing sutures, tissues or grafts 112, to the periosteum36. As illustrated, the staple 110 is operative to penetrate through asegment of tissue or graft 112 and become embedded within the periosteum36 such that the graft or tissue is caused to become affixed therewith.As illustrated in the top view portion of FIG. 14, the staple isoperative to assume a first insertion configuration whereby the prongs110 a, 110 b or such staple 110 are advanced through the graft 112 andultimately into the periosteum 36. Thereafter, as illustrated in the topview of FIG. 15, the prongs 110 a, 110 b are caused to embed within theperiosteum 36 to enhance the attachment therewith. As may be necessaryfor a certain application, such prongs 110 a, 110 b may even be causedto embed within the bone 38 lying there underneath to thus provide amore secure attachment.

To facilitate the ability of the staple 110 to secure the graft 112 tothe periosteum 36 in the aforementioned manner, it is contemplated thatsuch staple 110 may be formed of resilient, self-expanding orself-contracting material which is biased to the operative configurationshown in FIG. 15 such that when unconstrained, the opposed ends of thestaple 110 will become further embedded into the periosteum. Similarly,such staple may be fabricated from a plastically deformable materialwhich is initially formed to assume the insertion configuration depictedin FIG. 14, but can subsequently be deformed to assume the operativeconfiguration depicted in FIG. 15. As a still further alternative, suchstaple 110 may be formed from a shape-memory material, such as nitinol,which thus enables the staple to assume the insertion configurationdepicted in FIG. 14 when at room temperature, but transition to theoperative, more secure configuration depicted in FIG. 15 when warmed tobody temperature, as will occur such staple is deployed. As a furtheradvantage, to the extent it becomes necessary to remove or otherwisereposition such staple 110, it will be recognized by those skilled inthe art that removal of such staple 110 may be facilitated by merelycooling the same down by any of a variety of well-known methods,including applying cold saline thereto.

All of the affixation devices discussed herein, although havingwidespread applicability and substantial advantage over prior art anchordevices, and more particularly bone screws and bone anchors, areparticularly well suited in gynecologic, urologic and orthopedicsurgical applications. It is believed that such affixation devices areparticularly well suited for transvaginal sling surgery insofar as muchof the medical literature tends to indicate that in a vast majority ofpatients, the sling that is utilized in such procedures should be placedwith little to no tension at all, with the tension vector emanatingtherefrom being oriented in a direction well-suited to the piton portionof those embodying as depicted in FIGS. 6-8. Indeed, considerableauthority exists that optimal placement of the sling in transvaginalsling surgery occurs when the sling merely comes near or into contactwith the urethra. Affixation by attaching the sling merely to theperiosteum and not to the bone is thus believed to provide more thansufficient leverage or support to the sling in such applications, butyet have the further advantage of being exceptionally easy to secure andre-secure into position in a much less traumatic manner than the priorart devices.

Although the invention has been described herein with specific referenceto a presently preferred embodiment thereof, it will be appreciated bythose skilled in the art that various modifications, deletions, andalterations may be made to such preferred embodiment without departingfrom the spirit and scope of the invention. For example, it will berecognized that the, piton portion of any of the surgical implantsdisclosed herein may take any of a variety of forms such that the sameare caused to become more thoroughly seated in a position via theapplication of force in one direction, but yet become more easilywithdrawn when pulled rearwardly in a second direction. It is furthercontemplated that such embodiments may be formed from plasticallydeformable or shape-memory material to thus facilitate fixation of suchdevices at a selected target site. Moreover, it should be recognizedthat the affixation devices disclosed herein designed to affix sutures,grafts, tissues, synthetic materials, and the like to periosteum mayfurther be modified so that the same additionally penetrate into andbecome embedded within the bone lying thereunderneath. Specifically,with respect to the embodiment depicted in FIG. 10, one or more of thehooks may be sized and adapted to penetrate into the bone, similar tothe prongs formed on the implantable tack depicted in FIGS. 11-13.Likewise, the prongs of the staple element depicted in FIGS. 14 and 15may be designed to penetrate and embed within the bone. Accordingly, itis intended that all reasonably foreseeable additions, modifications,deletions and alterations be included within the scope of the inventionas defined in the following claims.

What is claimed is:
 1. A system for securing a sling into fixed positionwithin a target site of soft tissue within the body comprising: a) animplantable sling comprised of an elongate segment of material havingfirst and second opposed ends, each respective opposed end having ananchor mechanism formed thereon such that each respective anchormechanism is advanceable through said soft tissue at said selectedtarget site in a first direction and resistant to movement in adirection dissimilar from said first direction, each respective anchormechanism further being permanently fixable in position exclusivelywithin said soft tissue; and b) a non-mechanically assisted deploymentmechanism for positioning said anchor mechanisms of said implantablesling within said target site of said soft tissue, said deploymentmechanism comprising a manually operable handle having a deploymentmember extending distally therefrom, said deployment member beingdetachably fastenable to a respective one of said anchor mechanisms ofsaid implantable sling, said deployment mechanism further comprising anactuator mounted on a shaft axially moveable within the deploymentmember and being configured to insert said anchor mechanisms into saidtissue; wherein said actuator comprises a manually depressable buttoncoupled to the shaft extending within said deployment member andoperative to push said anchor mechanism through said soft tissue.